Staff Chemist - Synthetic Chemistry and API Manufacturing

Staff Chemist – Synthetic Chemistry and API Manufacturing MRIGlobal, 425 Dr Martin Luther King Jr Blvd, Kansas City, Missouri, United States of America Position Summary The Staff Chemist is a hands‑on, technical contributor within the synthetic chemistry and API manufacturing group. The primary focus of this role is the day‑to‑day execution of small molecule chemistry, including route and process development, optimization, and current Good Manufacturing Practice (cGMP) manufacturing in support of early‑phase clinical API production. Essential Functions Chemistry Execution (Primary) Perform hands‑on synthesis of small molecule APIs and intermediates at laboratory scale (milligram to multi‑gram quantities). Draft, review, and execute cGMP batch records for drug substance under cGMP conditions, while supporting non‑cGMP laboratory operations as needed. Carry out route scouting, process development, and optimization to define safe, scalable, and reproducible processes. Support scale‑up and technical transfer of API processes from the laboratory to early‑phase manufacturing scale (multi‑kilogram quantities). Characterize intermediates and products and interpret data from analytical techniques such as IR, MS, NMR, and U/HPLC, in coordination with analytical development. Maintain accurate, contemporaneous documentation, including laboratory records, protocols, and batch records. Contribute to technical problem‑solving and risk mitigation in support of client‑sponsored programs, including participation in technical discussions and data reviews. Technical Contribution Apply solid organic synthesis fundamentals and process chemistry expertise to solve technically complex and ambiguous problems. Apply phase‑appropriate cGMP and FDA guidance, including 21 CFR 210/211, ICH Q7, ICH Q11, and other relevant ICH guidelines, as well as pharmacopeial standards (USP, EP). Contribute to Chemistry, Manufacturing, and Controls (CMC) documentation supporting Investigational New Drug (IND) filings. Apply DOE and QbD approaches to develop robust API processes, where appropriate. Laboratory Operations & Growth Take ownership of assigned equipment and instrumentation, including routine maintenance, qualification support, and safe operation. Support laboratory cGMP compliance, safety practices, and a clean, well‑organized work environment. Provide informal technical guidance and mentorship to junior staff as appropriate. Success Factors Strong hands‑on expertise in synthetic organic chemistry and process chemistry. High attention to detail, especially in documentation. Sound technical judgment and the ability to troubleshoot and make decisions with incomplete information. Familiarity with cGMP drug substance manufacturing and FDA requirements (desired). Ability to draft and follow protocols, SOPs, test plans, and batch records. Effective written and oral communication, including the ability to convey technical detail to non‑specialists and clients. Ability to thrive in a fast‑paced, dynamic team environment where breadth and flexibility are essential. Qualifications PhD in Chemistry, Pharmaceutical Sciences, or a related field; or MS in a related field with approximately 3+ years of relevant experience; or BS in a related field with approximately 6+ years of relevant experience. Desired Qualifications Strongly desired: experience in process chemistry, API process development, and cGMP drug substance manufacturing. Pay Range $82,300 - $95,000 Benefits MRIGlobal provides comprehensive benefits including health and life insurance, disability coverage, gym reimbursement, mental health support, paid holidays, and PTO. Compliance Requirement Certain roles require up‑to‑date vaccinations. Employees must furnish proof of required vaccinations before commencing duties. Reasonable accommodation is available for medical conditions, disabilities, pregnancy, or religious belief. EEO Statement EOE, including disability/vets. #J-18808-Ljbffr MRIGlobal